Servicios de Laboratorio Clínico; Juego de Reactivos para Diagnóstico; Humanos; Juego de Reactivos para Diagnóstico/normas; Unión Europea; Servicios de Laboratorio Clínico/legislación & jurisprudencia

AB, accrediting body; BRCA1/2, breast cancer genes 1 and 2; CA, competent authority; CAPA, corrective and preventive actions; CDx, companion diagnostics; CGP, comprehensive genomic profile; CRGA, clinically relevant genomic alterations; EEA, European economic area; EFLM, European Federation of Clinical Chemistry and Laboratory Medicine; EMA, European Medicines Agency; EU, European Union; European Regulation 2017/746 on In-Vitro-Diagnostic Devices; FMEA, failure-mode effects analysis; GA, genomic alterations; GDPR, General Data Protection Regulation; HI, health institution; HRD, homologous recombination deficiency; HRR, homologous recombination repair; ISO 15189:2012; ISO, International Organization for Standardization; IVDD, In-Vitro Diagnostic Device Directive; IVDR, In-Vitro Diagnostic Device Regulation; LDT, laboratory-developed test; MDCG, Medical Device Coordination Group; MSI, micro satellite instability; MU, measurement uncertainty; NB, notified body; NGS, next generation sequencing; NTRK, neurotrophic tyrosine receptor kinase; PARPi, poly (ADP-ribose) polymerase inhibitors; PRRC, person responsible for regulatory compliance; PT, proficiency testing; RUO, research use only; RiliBÄk, Richtlinie der Bundesärztekammer zur Qualitätssicherung Laboratoriums medizinischer Untersuchungen; SOP, standard operating procedure; TMB, tumor mutational burden; UDI, unique device identifier; VAF, variant allele frequency; iQC, internal quality control; laboratory-developed tests for in-house use; method validation